drugset / Trial / NCT02141958
Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the safety and tolerability of ascending doses of a novel oral formulation of Fenretinide to adult cystic fibrosis (CF) patients, once-daily for 21 days (treatment cycle). This study will include up to three (3) dose levels with minimum 7 day breaks in between treatment cycles. For each dose level, blood samples will be collected for exploratory pharmacokinetic (PK) and pharmacodynamic (PD) evaluation.
Timeline
- Start
- 2014-04
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fenretinide | Small molecule | 100 mg | Oral |
| Subject | fenretinide | Small molecule | 200 mg | Oral |
| Subject | fenretinide | Small molecule | 300 mg | Oral |
| Subject | fenretinide | Small molecule | 400 mg | Oral |